MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-02-13 for DUREX manufactured by Reckitt Benckiser Healthcare Int. Limited.
[99983451]
Rb is awaiting the return of the product for quality analysis and also follow up information regarding the reported incident. The patient did not specify the variety of product that was used. The patient neither provided the batch details for the product nor returned any of the remaining unopened product for quality analysis. No further information is expected; therefore, the company is unable to conduct any further investigation at this moment in time. The product labelling states that "no method of contraception can provide 100% protection against pregnancy or the transmission of hiv and stis. If you are worried that you or your partner may have become pregnant or infected, contact your doctor immediately. " the company's assessment for this case is serious and possible
Patient Sequence No: 1, Text Type: N, H10
[99983452]
Ectopic pregnancy [ectopic pregnancy] fallopian tube ruptured [fallopian tube disorder] condom split [device breakage]. Case description: initial report, received date: 22-jan-2018. Received from consumer relations, country: (b)(6), reference no: (b)(4). Suspect product: durex unspecified condoms. Case reference number (b)(6) is a spontaneous case report sent by a consumer which refers to a female age unknown. It was reported that on an unknown date, a female patient of an unknown age used durex unspecified condoms for an unknown indication. Patient stated that on several occasions the condom had split. She stated that she took a contraception pill as well. Patient stated that on one occasion a split condom resulted in an ectopic pregnancy. Patient stated that she had not even contemplated being pregnant until she collapsed when fallopian tube ruptured. The case was deemed serious because it was classed as medically significant due to ectopic pregnancy. No further information was available at the time of report. Case assessment of durex unspecified condoms is as follows: the reported assessment has not been provided, case relatedness is possible. The company's assessment is serious with a relatedness of possible and unknown. Case outcome: unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003071219-2018-00001 |
| MDR Report Key | 7268922 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-02-13 |
| Date of Report | 2018-01-22 |
| Date Mfgr Received | 2018-01-22 |
| Date Added to Maude | 2018-02-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JOANNE MARTINEZ |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal | HU8 7DS |
| Manufacturer G1 | RECKITT BENCKISER HEALTHCARE INT. LIMITED |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU8 7DS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUREX |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2018-02-13 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RECKITT BENCKISER HEALTHCARE INT. LIMITED |
| Manufacturer Address | DANSOM LANE HULL, HU8 7DS UK HU8 7DS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-13 |